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A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices
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A Tale of Two Cities: Working Between the Different Worlds of Pharmaceuticals and Medical Devices

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This presentation was given at the Clinical Research Symposium of the Children’s Medical Center, Dallas, TX in November 2011.

This presentation was given at the Clinical Research Symposium of the Children’s Medical Center, Dallas, TX in November 2011.

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  • 1. A Tale of Two CitiesWorking Between the DifferentWorlds of Pharmaceuticals andMedical DevicesPresented byPaul Below, CCRA,CCRTP. Below Consulting, Inc.
  • 2. Learning Objectives• Define drugs and medical devices• Review major differences between pharmaceutical and device industries• Review FDA structure and regulatory authority over drugs and devices• Review requirements for investigational drug and device applications Copyright 2011 © P. Below Consulting, Inc.
  • 3. Learning Objectives (cont.)• Review different pathways for marketing approval for drugs and devices• Review differences in study design in drug and device clinical trials• Review sponsor and investigator responsibilities for conducting clinical trials with drugs and devices Copyright 2011 © P. Below Consulting, Inc.
  • 4. DefinitionsDrug vs. Device Copyright 2011 © P. Below Consulting, Inc.
  • 5. Definitions Drug1 Articles other than food listed in the United States Pharmacopeia (USP) or the National Formulary (NF) Copyright 2011 © P. Below Consulting, Inc.
  • 6. Definitions Drug Medical Device1 Articles other than 2 An food listed in the instrument, apparatu United States s, implement, machi Pharmacopeia ne, implant, or in (USP) or the vitro reagent listed in National Formulary the USP or NF (NF) Copyright 2011 © P. Below Consulting, Inc.
  • 7. Definitions (cont.) Drug1 Intended to diagnose, cure, mitig ate, treat, or prevent disease Affects the structure & function of the human body Copyright 2011 © P. Below Consulting, Inc.
  • 8. Definitions (cont.) Drug Medical Device1 Intended to 2 Same as drugs plus diagnose, cure, mitig … ate, treat, or prevent Does not achieve disease primary effect Affects the structure through chemical & function of the action human body Is not dependent on being metabolized Copyright 2011 © P. Below Consulting, Inc.
  • 9. Combination Devices• A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity (defined in 21 CFR 3.2e).• Regulatory pathway is defined by the primary mechanism of action Copyright 2011 © P. Below Consulting, Inc.
  • 10. Copyright 2011 © P. Below Consulting, Inc.
  • 11. Investigational Product Definitions Drug1 Being used in a clinical investigation Also includes biologic products used in vitro for diagnostic purposes Copyright 2011 © P. Below Consulting, Inc.
  • 12. Investigational Product Definitions Drug Medical Device1 Being used in a 2 Being used in a clinical investigation clinical investigation Also includes Not in commercial biologic products distribution used in vitro for Three classes of diagnostic purposes devices based on risk and required controls Copyright 2011 © P. Below Consulting, Inc.
  • 13. Device Classification (21 CFR 860)Class I – Low Risk Class II – Moderate Risk 1 General controls only – No 2 General & special FDA review required controls (performance. Reasonable assurance of standards, the safety and post-market surveillance) effectiveness Cleared by FDA (510K Examples: surgical process) instruments, wound Examples: non-implanted dressings, contact pumps, vascular lenses, toothbrush clamps, sutures, ECGs, u rology catheters Copyright 2011 © P. Below Consulting, Inc.
  • 14. Device Classification (21 CFR 860) Class III – High Risk 3 Clinical data & FDA approval required Life-supporting, life- sustaining, important in preventing impairment, potential for unreasonable risk Examples: pacemakers, defibrillators, vascular grafts, angioplasty catheters, stents Copyright 2011 © P. Below Consulting, Inc.
  • 15. Device Classification• Devices classification depends on intended use and indications for use• For example, a scalpel’s intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device’s labeling such as, “for making incisions in the cornea”• Indications for use can be found in the device’s labeling Copyright 2011 © P. Below Consulting, Inc.
  • 16. Device ClassificationDevice classification database on FDAwebsite:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm Copyright 2011 © P. Below Consulting, Inc.
  • 17. Industry Differences Drug vs. Device Copyright 2011 © P. Below Consulting, Inc.
  • 18. Major Industry Differences • Local vs. systemic effects Mechanism of Action • Physical effects vs. pharmacokinetic Business Environment Copyright 2011 © P. Below Consulting, Inc.
  • 19. Major Industry Differences • Local vs. systemic effects Mechanism of Action • Physical effects vs. pharmacokinetic • Wide variety of device types Business • Number and size of companies Environment • Rapid changes in device technology Copyright 2011 © P. Below Consulting, Inc.
  • 20. Major Industry Differences (cont.) • Length of time & money Product Development • Pre-clinical differences • Different regulatory pathways for marketing approval • Clinical trial differences • Post-approval surveillance, device tracking, conditional approval requiring long-term study Copyright 2011 © P. Below Consulting, Inc.
  • 21. Pharmaceutical Development Chemical Clinical Trials: Supplemental reporting Synth. Phase I Phase IV NDA 1.5 yrs Pharmacology Phase II Postmarketing Toxicology Phase III Clinical education 6 yrs 4.8 yrs 8-10 yrs Copyright 2011 © P. Below Consulting, Inc.
  • 22. Device Development Bench Testing & Feasibility study Human Postmarket studies GLP Studies Studies Supplemental reporting PMA - 14 mos Clinical education Medicare review 12 - 24 3-9 6 - 36 mos mos mos Copyright 2011 © P. Below Consulting, Inc.
  • 23. FDA Governance• Drugs and devices are both regulated by the US Food and Drug Administration (Department of Health & Human Services)• FDA’s legal authority comes from the Federal Food, Drug, and Cosmetic Act (FD&C) Copyright 2011 © P. Below Consulting, Inc.
  • 24. FDA Governance Drug Device1 Federal 2 Federal requirements requirements governing governing safety investigations enacted were enacted in in FD&C amendments FD&C amendments in 1976 and 1990 in 1938 and efficacy in 1962 Center for Drug Center for Devices Evaluation and and Radiologic Research (CDER) Health (CDRH) Copyright 2011 © P. Below Consulting, Inc.
  • 25. FDA Regulations 21 CFR Part 312 21 CFR Part 812 (investigational (investigational drugs) devices) 21 CFR Part 314 21 CFR Part 814 (market approval) (market approval) Copyright 2011 © P. Below Consulting, Inc.
  • 26. Common Regulations forDrugs and Devices✓ 1 21 CFR Part 50 Protection of Human Subjects✓ 2 21 CFR Part 56 Institutional Review Boards✓ 3 21 CFR Part 54 Financial Disclosure✓ 4 21 CFR Part 11 Electronic Records✓ 5 45 CFR Part 160 & Part 164 HIPAA Privacy Rule 6 Copyright 2011 © P. Below Consulting, Inc.
  • 27. Investigational Product Applications Drug vs. Device Copyright 2011 © P. Below Consulting, Inc.
  • 28. Investigational Product Applications Drug Device1 21 CFR Part 312 2 21 CFR Part 812 Investigational New Investigational Device Drug (IND) Exemption (IDE)• Both are requests for exemption from Federal law prohibiting shipment of an unapproved drug or device in interstate commerce• Both also permit use of product in a clinical study to collect safety and efficacy data Copyright 2011 © P. Below Consulting, Inc.
  • 29. Investigational Product Applications Drug Device1 21 CFR Part 312.20 2 21 CFR Part 812.20 IND must be IDE required prior to submitted to FDA conducting a clinical prior to conducting a investigation clinical investigation Two paths: significant with an vs. non-significant risk investigational drug studies Exemptions from IDEs Exemptions from (812.2c) INDs (312.2b) Copyright 2011 © P. Below Consulting, Inc.
  • 30. IND Exemptions Lawfully marketed in the US and: Not intended to support a new indication; Not intended to support a change in advertising; Doesn’t involve a factor that increases risk of use; Conducted in compliance with IRB and Informed Consent Complies with promotion & charging rules (21 CFR 312.7) Copyright 2011 © P. Below Consulting, Inc.
  • 31. IDE Exemptions Used in accordance with approved indications or: Non-invasive diagnostic; Consumer preference testing; Solely for veterinary use; Research on or with lab animals; Custom device (not being used to determine safety and efficacy for commercial distribution) Copyright 2011 © P. Below Consulting, Inc.
  • 32. IDE Decision Model Device approved for Exempt C commercial release & used YES from according to IDE labeling or otherwise exempt? NO Abbreviated IDE required FDA empowers the IRB Significa NO to approve the IDE nt Risk Study? Full IDE required YES Must submit for approval to FDA Copyright 2011 © P. Below Consulting, Inc.
  • 33. IND Content • Form FDA 1571 • Introductory statement • General investigational plan • Investigator brochure • Protocols (study, investigator, facilities, IRB) • Chemistry, manufacturing, control data • Environmental impact statement • Pharmacology and toxicology data • Previous human experience Copyright 2011 © P. Below Consulting, Inc.
  • 34. IND Content (Parts Unique to Drugs) • Form FDA 1571 • Introductory statement • General investigational plan • Investigator brochure • Protocols (study, investigator, facilities, IRB) • Chemistry, manufacturing, control data • Environmental impact statement • Pharmacology and toxicology data • Previous human experience Copyright 2011 © P. Below Consulting, Inc.
  • 35. IDE Content • Report of prior investigations • Protocol including case report forms • Risk analysis • Description of the device • Monitoring procedures • Manufacturing info & environmental impact • Investigator information • Sales information • Labeling • Informed consent materials and IRB info Copyright 2011 © P. Below Consulting, Inc.
  • 36. IDE Content (Parts Unique to Devices) • Report of prior investigations • Protocol including case report forms • Risk analysis • Description of the device • Monitoring procedures • Manufacturing info & environmental impact • Investigator information • Sales information • Labeling • Informed consent materials and IRB info Copyright 2011 © P. Below Consulting, Inc.
  • 37. Marketing Applications Drug Device1 21 CFR Part 314 2 21 CFR Part 814 New Drug Premarket approval Application (NDA) application (PMA) – Class III devices Supplemental NDA Supplemental PMA Abbreviated NDA 510(k) Clearance – (generics) Class II devices Copyright 2011 © P. Below Consulting, Inc.
  • 38. Copyright 2011 © P. Below Consulting, Inc.
  • 39. Study DesignDrug vs. Device Copyright 2011 © P. Below Consulting, Inc.
  • 40. Study Design Differences Number of • Single confirmatory trial for Required Studies devices • Two well controlled trials for drugs Study Phases Copyright 2011 © P. Below Consulting, Inc.
  • 41. Study Design Differences Number of • Single confirmatory trial for Required Studies devices • Two well controlled trials for drugs • Feasibility and pivotal studies for Study devices Phases • Phase I-III studies for drugs Copyright 2011 © P. Below Consulting, Inc.
  • 42. Study Design Differences (cont.) Number of • Hundreds of subjects for Subjects devices • Thousands of subjects for drugs Study Phases Copyright 2011 © P. Below Consulting, Inc.
  • 43. Study Design Differences (cont.) Number of • Hundreds for devices Subjects • Thousands for drugs • Weeks to months for devices Length of Studies • Months to years for drugs Copyright 2011 © P. Below Consulting, Inc.
  • 44. Study Design Differences (cont.) • Placebo control vs. “sham” Type of control Controls • Device trials may not be randomized • Blinding/masking often not possible with devices Product Obsolescence Copyright 2011 © P. Below Consulting, Inc.
  • 45. Study Design Differences (cont.) • Placebo control vs. “sham” Type of control Controls • Device trials may not be randomized • Blinding/masking often not possible with devices • Device technology may change Product during the study Obsolescence Copyright 2011 © P. Below Consulting, Inc.
  • 46. Sponsor Responsibilities Drug Device1 21 CFR Part 312.50- 2 21 CFR Part 812.40 52 Same as drug but Select qualified … investigators No language on Provide “transfer of investigators info to obligations” to conduct trial CRO Ensure proper monitoring Can transfer obligations to a CRO Copyright 2011 © P. Below Consulting, Inc.
  • 47. Investigator Selection Drug Device1 21 CFR Part 312.53 2 21 CFR Part 812.43 Select investigators Same as drug but qualified by training … and experience No 1572: Ship invest. product Investigator only to participating agreement instead investigators If investigators are Obtain investigator involved in information terminated (CV, Form FDA research, obtain 1572, financial) explanation of the circumstances Copyright 2011 © P. Below Consulting, Inc.
  • 48. Special Device Challenges -Selecting Investigators• Smaller pool of qualified investigators with device expertise• Marketing has a larger role in site selection (investigator is viewed as “customer”)• Device investigators pay a larger role in publication strategy (important for reimbursement) and also adoption of the device by the medical community Copyright 2011 © P. Below Consulting, Inc.
  • 49. Monitor Selection Drug Device1 21 CFR Part 312.53d 2 21 CFR Part 812.43d Select monitors Same as drug … qualified by training and experience to monitor the investigation Copyright 2011 © P. Below Consulting, Inc.
  • 50. Monitoring Investigations Drug Device1 21 CFR Part 312.56 2 21 CFR Part 812.46 If non-compliance Same as drug … is discovered, Don’t secure compliance dispose/return or discontinue IP device if it would shipments, jeopardize subject terminate (eg., explant) participation, and dispose/return of IP Copyright 2011 © P. Below Consulting, Inc.
  • 51. Monitoring Investigations (cont.) Drug Device1 21 CFR Part 312.70 2 21 CFR Part 812.119 Disqualification of Same as drug … investigators by the FDA Copyright 2011 © P. Below Consulting, Inc.
  • 52. Monitoring Investigations (cont.) Drug Device1 21 CFR Part 312.56 2 21 CFR Part 812.46 Discontinue Same as drug … investigations if Can resume investigational terminated studies product presents of a significant risk an unreasonable device only after risk FDA and IRB approval Copyright 2011 © P. Below Consulting, Inc.
  • 53. Sponsor Reporting to FDA Drug Device1 21 CFR Part 312.30- 2 21 CFR Part 812.35 31 IDE supplemental Protocol applications amendments and IND amendments Copyright 2011 © P. Below Consulting, Inc.
  • 54. Sponsor Reporting to FDA (cont.) Drug Device1 21 CFR Part 312.32 2 21 CFR Part 812.150b IND Safety Unanticipated Reports of serious adverse device & unexpected effects - UADE drug-related adverse events Copyright 2011 © P. Below Consulting, Inc.
  • 55. The Monitor, June 2009 Copyright 2011 © P. Below Consulting, Inc.
  • 56. Sponsor Reporting to FDA (cont.) Drug Device1 21 CFR Part 312.33 2 21 CFR Part 812.150b IND Annual Annual progress Reports reports and final report, if significant risk device Copyright 2011 © P. Below Consulting, Inc.
  • 57. Sponsor Reporting to FDA (cont.) Drug Device1 21 CFR Part 312.30 2 21 CFR Part 812.150b New investigators Current investigator reported as part of list every 6-months protocol amendments Significant risk determination by IRB Any sponsor request for device return, repair, or disposition Withdrawal of IRB Copyright 2011 © P. Below Consulting, Inc.
  • 58. Sponsor Reports to Investigators Drug Device1 21 CFR Part 312.55 2 21 CFR Part 812.45 Prior to the Prior to study, provide study, provide investigator investigational plan brochure (IB) and report of prior investigations Copyright 2011 © P. Below Consulting, Inc.
  • 59. Sponsor Reports to Investigators Drug Device1 21 CFR Part 312.55 2 21 CFR Part 812.150 Report new Report UADEs and observations withdrawal of IRB through updated and/or FDA IB, letters, and IND approval safety reports Copyright 2011 © P. Below Consulting, Inc.
  • 60. Sponsor Records Drug Device1 21 CFR Part 312.57 2 21 CFR Part 812.150 Maintain Same as drug but investigator records … including financial disclosure Retention for 2 years after no Maintain records of longer needed to IP support a shipment/dispositio marketing n application Retention for 2 Provisions for years after market transferring records approval or invest. custody to another Copyright 2011 © P. Below Consulting, Inc.
  • 61. Investigator Responsibilities Drug Device1 21 CFR Part 312.60 2 21 CFR Part 812.110 Ensure Same as drug but investigation … conducted according to Language investigational plan permitting potential and FDA subject recruitment regulations (eg, interest), but not consent, prior Protect to IRB and FDA rights, safety, welfar approval e of subjects Ensure informed Copyright 2011 © P. Below Consulting, Inc.
  • 62. Special Device Challenges –Obtaining Informed Consent• Timing of informed consent can be difficult as subjects often enroll on same day of treatment;• Indications for use of specific device may not be confirmed until some time during a surgical procedure; and• Subjects may require pre-medication for treatment Copyright 2011 © P. Below Consulting, Inc.
  • 63. IP Administration Drug Device1 21 CFR Part 312.61 2 21 CFR Part 812.110c Administer IP to Same as drug but subjects under … personal supervision or Permit device to be supervision of used with subjects subinvestigator under the investigator’s Supply IP only to supervision authorized persons (no language about delegation to others) Copyright 2011 © P. Below Consulting, Inc.
  • 64. Special Device Challenges –Device Administration• Investigator skill with equipment varies• Investigator training on device use may be difficult due to influx of new residents and fellows and rapid changes in technology Copyright 2011 © P. Below Consulting, Inc.
  • 65. Copyright 2011 © P. Below Consulting, Inc.
  • 66. IP Disposition Drug Device1 21 CFR Part 2 21 CFR Part 812.110c 312.59, 62a Same as drug … If investigation is completed or terminated, return supplies to sponsor or dispose as directed Copyright 2011 © P. Below Consulting, Inc.
  • 67. Special Device Challenges –Device Accountability• Monitoring and controlling device inventory may be difficult due to storage location (ie, O.R. supply room) and device size and portability.• Some devices require “multi-use” accountability• Changes in device technology during trial may require frequent inventory changes Copyright 2011 © P. Below Consulting, Inc.
  • 68. Investigator Reporting Drug Device1 21 CFR Part 312.64 2 21 CFR Part 812.150a Progress reports Similar to drug but and final report to … sponsor Safety reports of Safety reports of UADEs to sponsor causally-related and IRB adverse events to sponsor and IRB Report deviations from invest. plan to Financial disclosure protect a subject in reports to sponsor an emergency to sponsor and IRB Copyright 2011 © P. Below Consulting, Inc.
  • 69. Investigator Records Drug Device1 21 CFR Part 312.62 2 21 CFR Part 812.140 Records of drug Same as drug but disposition … Subject case All correspondence histories including with signed & dated IRB, sponsor, other consent forms investigators, and FDA Documentation that consent obtained Dates of and prior to participation reasons for in the study deviations from the protocolCopyright 2011 © P. Below Consulting, Inc.
  • 70. Records Inspection by the FDA Drug Device1 21 CFR Part 2 21 CFR Part 812.145 312.58, 68 Same as drug … Sponsors and investigators will permit FDA to access, copy, and verify all records related to clinical investigations Investigator records may identify subjects if FDA finds necessary Copyright 2011 © P. Below Consulting, Inc.
  • 71. Other Similar IP Regulations21 CFR Part 312.36 21 CFR Part 812.5 Labeling, Promotion & Charging21 CFR Part 312.34 21 CFR Part 812.36 Treatment Use21 CFR Part 312.36 21 CFR Part 812.47 Emergency Use Copyright 2011 © P. Below Consulting, Inc.
  • 72. Questions
  • 73. Contact InformationPaul Below• P. Below Consulting, Inc. & GCP Training Specialists Burnsville, MN• Office: (612) 643-5598• Email: paul@pbelow-consulting.com• Website: www.pbelow-consulting.com

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